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NCT Number: NCT01857583

Safety and Pharmacokinetics Study of DU-176b Administered to Patients With Severe Renal Impairment Undergoing Orthopedic Surgery of The Lower Limbs

To assess the safety and pharmacokinetics of DU-176b administered to patients with severe renal impairment undergoing orthopedic surgery of the lower limbs, compared with DU-176b administered to patients with mild renal impairment (MiRI) undergoing orthopedic surgery of the lower limbs.

For reference, the safety of DU-176b in patients with SRI undergoing orthopedic surgery of the lower limbs will be compared with that of fondaparinux.

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Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Embolism and Thrombosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Thromboembolism Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Toyooka Chuo Hospital

Asahikawa, Hokkaido Prefecture, 078-8237, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with SRI or MiRI undergoing orthopedic surgery of the lower limbs

Exclusion criteria

  • Patients who are on hemodialysis or are scheduled to undergo hemodialysis during the study period
  • Patients who are at a significantly high risk for bleeding or thromboembolism
  • Patients who are receiving another antithrombotic therapy and are unable to suspend the therapy
  • Patients who have evidence of hepatic function test abnormalities

Treatment and study plan

15mg DU-176b

Drug

Other names: edoxaban

30mg DU-176b

Drug

Other names: edoxaban

fondaparinux

Drug

Primary outcomes

  1. Incidence of Any Adjudicated Bleeding Events

    Time frame: 14 days

    Incidence of any adjudicated bleeding events (including major bleeding, clinically relevant non-major bleeding, and minor bleeding).

  2. Incidence of Adverse Events

    Time frame: 1 month

  3. Incidence of Adverse Drug Reactions

    Time frame: 1 month

  4. Plasma Concentration of DU-176b

    Time frame: 14 days

  5. Plasma Concentration of D21-2393

    Time frame: 14 days

Secondary outcomes

  1. Incidence of Adjudicated Thromboembolic Events

    Time frame: 1 month

    Incidence of adjudicated thromboembolic events (symptomatic Deep Vein Thrombosis (DVT), symptomatic Pulmonary Thromboembolism (PTE), Venous Thromboembolism (VTE) related deaths).

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo Co., Ltd.

Industry

Registry information

Official study title

Phase III Clinical Study of DU-176b (Venous Thromboembolism): Japanese, Multicenter, Open-label Study of DU-176b in Patients With Severe Renal Impairment (SRI) Undergoing Orthopedic Surgery of the Lower Limbs

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
May 20, 2013
Registry last updated
Mar 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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